Institutional Review Board (IRB)

Additional Topics in This Section

Protecting Research Participants

The purpose of the Institutional Review Board (IRB) is to protect human subjects involved in research.

All federally funded clinical trials as well as studies evaluating a new drug or medical device subject to Food and Drug Administration regulation must be reviewed and approved by an Institutional Review Board (IRB). Many institutions, including Fox Chase Cancer Center, require that all clinical trials, regardless of funding, be reviewed and approved by a local IRB, which includes doctors, researchers, community leaders and other members of the community.

The human subjects protection program at Fox Chase Cancer Center holds full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

Participation is voluntary and involves a rigorous and thorough review of an institute's internal program for protecting patients who enroll in clinical research.

Fox Chase received re-accreditation, effective June 2007. in July 2004 Fox Chase was one of the first institutions in the United States, and the first freestanding comprehensive cancer center (and the first program in Pennsylvania), to be accredited by AAHRPP. More

Research with people is conducted according to strict scientific and ethical principles. Every clinical trial has a protocol, or action plan, on how to conduct the trial. The plan describes what will be done in the study, how it will be conducted and why each part of the study is necessary. The same protocol is used by every doctor or cancer research center taking part in the clinical trial.

After review by the Research Review Committee (RRC), each protocol involving human subjects is initially reviewed by the Board and, if approved, is reviewed on a continuing basis. A progress report and updated consent form are submitted to and reviewed by the Board at least annually and more frequently if needed.

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